Quality Compliance

Quality Management and Regulatory Compliance are core business processes within Life Sciences . As listed in EudraLex, the pharmaceutical industry of the European Union maintains high standards of quality Management in the development, manufacture and control of medicinal products. A system of marketing authorizations ensures that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality and efficacy.

GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use and adhere to quality processes during manufacturing, control, storage and distribution.
Compliance with GxP rules is decisive for ensuring that end customers have access to high-quality products, which is why all pharmaceutical industry operations must be performed in accordance with GxP requirements.

ALTEN Belgium supports its customers throughout the product lifecycle, offering tailored solutions in all GxP areas:

Guarantees that production acitivites are performed and documented according to GMP requirements and quality systems (change control, deviation, CAPA etc.)

Ensures that activities related to equipment qualification and process validation are performed and documented according to GMP and quality requirements.

Provides that technical service activities (calibration, metrology, utilities management etc.) are performed and documented according to GMP and quality system requirements.

ALTEN Belgium guides, leads or supports its customers through the following activities:

• Preparation and assistance with audits (pre- and post-audits)
• Handling of deviations
• CAPA monitoring and management
• Follow-up and handling of customer complaints
• Authoring and implementing SOPs
• Evaluation and design of staff training programs
• Periodic Quality Reviews